On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...

DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...

On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The ...

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "IQ, OQ, PQ in the Verification and Validation Process (Jan 28, 2026)" training has been added to ResearchAndMarkets.com's offering. This course will ...

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...

The computer vision leader offers controlled release cloud-based software to speed up innovation for life-enhancing drugs and medical devices PALO ALTO, Calif., May 2, 2023 /PRNewswire/ -- Landing AI, ...

MAPLE GROVE, Minn., June 22, 2023 /PRNewswire/ -- ZEISS is now offering customers validation solutions for their ZEISS Coordinate Measuring Machines (CMMs). The validation of quality assurance systems ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.